Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)— 510(k) K261740

Name: FDA 510(k) clearance K261740
Creator: U.S. Food and Drug Administration
Published: 2026-10-27

Substantially Equivalent

Robotrak Technologies Co., Ltd.

FDA 510(k) clearance K261740 for Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV), Substantially Equivalent on 2026-10-27. Applicant: Robotrak Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Robotrak Technologies Co., Ltd.
Product code: Product code MYC
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2026-05-27
Decision date: 2026-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

Download summary PDF View on FDA.gov ↗

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